MENTOR MemoryShape Breast Implant 3341055Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00081317005292), received between Oct 8, 2019 and Feb 3, 2025 — classified as 12 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 225CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING BREAST IMPLANT ILLNESS, FEELING RESTRICTED, TINGLY FEELINGS, AND OTHER UNSPECIFIED HEALTH ISSUES. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED; HOWEVER, AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE DATE OF EVENT WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21299636 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 225CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING BREAST IMPLANT ILLNESS, FEELING RESTRICTED, TINGLY FEELINGS, AND OTHER UNSPECIFIED HEALTH ISSUES. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED; HOWEVER, AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE DATE OF EVENT WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21299634 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL (SUBJECT ID: (B)(6)). IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 225CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED CUTANEOUS CONTOUR DEFORMITY ON AN UNKNOWN SIDE POST-OPERATIVELY. THE PATIENT REPORTED ISSUES WITH RIPPLING/WRINKLING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. BOT OF THE PATIENT¿S DEVICES WERE REPORTED; HOWEVER, IT IS UNKNOWN WHICH DEVICE BELONGS TO THE IMPACTED SIDE. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Wrinkling

  MAUDE report 19463124 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL (SUBJECT ID: (B)(6). IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 225CC (LEFT) AND 235CC (RIGHT) MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING NON-RHEUMATOLOGIC DEGENERATIVE ARTHRITIS POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18232177 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 45-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 255CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYSHAPE BREAST IMPLANT 225CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 16881772 ↗
• InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ASIAN FEMALE PATIENT UNDERWENT, AS PART OF A CLINICAL STUDY, BREAST RECONSTRUCTION REVISION WITH A 225CC MENTOR MEMORYSHAPE BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST WRINKLING. AS A RESULT, THE PATIENT UNDERWENT FAT GRAFTING AND NIPPLE RECONSTRUCTION ON (B)(6) 2021.

  Patient problems: Wrinkling

  MAUDE report 13518839 ↗
• InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ASIAN FEMALE PATIENT UNDERWENT, AS PART OF A CLINICAL STUDY, PRIMARY BREAST RECONSTRUCTION WITH TWO 225CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST INFECTION AND RIGHT BREAST WRINKLING. AS A RESULT, THE PATIENT UNDERWENT REMOVAL OF THE LEFT BREAST IMPLANT ON (B)(6), 2021. THE LEFT BREAST IMPLANT WAS REPLACED ON (B)(6), 2021 WITH A 225CC MENTOR MEMORYSHAPE BREAST IMPLANT (CATALOG: 3341055 LOT: 7548689 SN: (B)(4)). SURGICAL INTERVENTION WAS DONE ON THE RIGHT BREAST ON (B)(6), 2021. THE PATIENT UNDERWENT FAT GRAFTING AND NIPPLE RECONSTRUCTION. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS. COMPLICATION ON THE LEFT BREAST/IMPLANT HAS BEEN REPORTED UNDER MRN: 1645337-2021-05877.

  Patient problems: Post Operative Wound Infection; Wrinkling

  MAUDE report 13518838 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST RECONSTRUCTION WITH 225CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED LEFT-SIDED WOUND INFECTION POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021.

  Patient problems: Post Operative Wound Infection

  MAUDE report 11882218 ↗
• InjuryJun 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 225CC MENTOR MEMORYSHAPE BREAST IMPLANTS ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10129184 ↗
• InjuryJun 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 225CC MENTOR MEMORYSHAPE BREAST IMPLANTS ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10129181 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT CONTAINS THE SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 225CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED POSTOPERATIVE BILATERAL CAPSULAR CONTRACTURE (GRADE 3 FOR LEFT AND GRADE 3.5 FOR RIGHT). AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH TWO 225CC MENTOR MEMORYGEL BREAST IMPLANTS (CATALOG #:3502251BC) ON (B)(6) 2019. THE GRADES ON THE BILATERAL CAPSULAR CONTRACTURE WERE CONFIRMED BY A SURGEON DURING THE REVISION SURGERY ON (B)(6) 2019. THIS REPORT IS FOR THE LEFT PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9169023 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT CONTAINS THE SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 225CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED POSTOPERATIVE BILATERAL CAPSULAR CONTRACTURE (GRADE 3 FOR LEFT AND GRADE 3.5 FOR RIGHT). AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH TWO 225CC MENTOR MEMORYGEL BREAST IMPLANTS (CATALOG #:3502251BC) ON (B)(6) 2019. THE GRADES ON THE BILATERAL CAPSULAR CONTRACTURE WERE CONFIRMED BY A SURGEON DURING THE REVISION SURGERY ON (B)(6) 2019. THIS REPORT IS FOR THE RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9169009 ↗